Land: Nieuw-Zeeland
Taal: Engels
Bron: Medsafe (Medicines Safety Authority)
Methyldopa sesquihydrate 283mg equivalent to to 250 mg methyldopa anhydrous;
Viatris Limited
Methyldopa sesquihydrate 283 mg (equiv. to 250 mg methyldopa anhydrous)
250 mg
Tablet
Active: Methyldopa sesquihydrate 283mg equivalent to to 250 mg methyldopa anhydrous Excipient: Citric acid Colloidal silicon dioxide Disodium edetate dihydrate Ethylcellulose Guar gum Magnesium stearate Opadry yellow OY-8462 Purified water Sodium starch glycolate
Bottle, plastic, HDPE with PP child resistant cap, 100 tablets, 100 tablets
Prescription
Prescription
Sicor (Societa Italiana Corticosteroidi) Srl
Hypertension (mild, moderate or severe).
Package - Contents - Shelf Life: Bottle, plastic, HDPE with green PP cap - 100 tablets - 36 months from date of manufacture stored at or below 30°C. (white bottle at Alphapharm Pty Ltd and blue bottle at Mylan Laboratories Limited) - Bottle, plastic, - 500 tablets - 36 months from date of manufacture stored at or below 30°C. (white bottle at Alphapharm Pty Ltd and blue bottle at Mylan Laboratories Limited)
1981-04-23
Page 1 of 4 NEW ZEALAND CONSUMER MEDICINE INFORMATION METHYLDOPA VIATRIS _METHYLDOPA 250 MG, FILM COATED TABLET_ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking METHYLDOPA VIATRIS. This leaflet answers some common questions about METHYLDOPA VIATRIS. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking METHYLDOPA VIATRIS against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT METHYLDOPA VIATRIS IS USED FOR Your METHYLDOPA VIATRIS tablets contain the active ingredient methyldopa. METHYLDOPA VIATRIS is used to lower high blood pressure, also called hypertension. It works by widening blood vessels so that blood passes through them more easily. This helps to lower blood pressure. There is no evidence that METHYLDOPA VIATRIS is addictive. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor’s prescription. BEFORE YOU TAKE METHYLDOPA VIATRIS _WHEN YOU MUST NOT TAKE _ _IT_ DO NOT TAKE METHYLDOPA VIATRIS IF YOU HAVE AN ALLERGY TO: any medicine containing methyldopa any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: shortness of breath; wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. Do not take METHYLDOPA VIATRIS if you: have liver disease such as hepatitis or cirrhosis take a monoamine oxidase inhibitor (MAOI), a medicine used to treat depression and Parkinson’s disease are being treated for depression have phaeochromocytoma or paranganglioma (rare tumours of the adren Lees het volledige document
Page 1 of 8 NEW ZEALAND DATA SHEET METHYLDOPA VIATRIS 1. PRODUCT NAME Methyldopa Viatris, 250 mg, film coated tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 250 mg of methyldopa (as anhydrous). Excipients with known effect: contains sulfites and galactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM 250 mg tablet: Yellow film coated normal convex tablets, 10.2 mm in diameter, imprinted ‘MD’ over ‘250’ on one side and ‘G’ on the other. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ Hypertension (mild, moderate or severe). _4.2_ _DOSE AND METHOD OF ADMINISTRATION_ DOSE Methyldopa is largely excreted by the kidney and patients with impaired renal function may respond to smaller doses. Syncope in older patients may be related to an increased sensitivity and advanced arteriosclerotic vascular disease. This may be avoided by lower doses. Withdrawal of methyldopa is followed by return of hypertension usually within 48 hours. This is not complicated by an overshoot of blood pressure. Therapy with methyldopa may be initiated in most patients already on treatment with other antihypertensive agents. Methyldopa may also be used concomitantly with amiloride/hydrochlorothiazide tablets or beta- blocking agents. such as timolol maleate. Many patients can be controlled with one tablet of amiloride 5 mg/hydrochlorothiazide 50 mg and 500 mg of methyldopa administered once daily. When methyldopa is given to patients on other antihypertensives, the dose of these agents may need to be adjusted to effect a smooth transition. Terminate these antihypertensive medications gradually if required (see manufacturers’ recommendations on stopping these medicines). Following such previous antihypertensive therapy, the initial dose of methyldopa should be limited to not more than 500 mg daily and increased as required at intervals of not less than 2 days. Page 2 of 8 _ADULTS_ The usual starting dosage of methyldopa is 250 mg two or three times a day in the Lees het volledige document